EUR-Lex Official Journal · May 04, 2026

Commission Implementing Regulation (EU) 2026/977 laying down uniform quality management and procedural requirements for notified body conformity assessment activities under MDR and IVDR

Original title: Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council

Implementing regulation establishing uniform quality management and procedural requirements for notified bodies conducting conformity assessment under MDR and IVDR.

High obligation Framework Medical Devices & IVD EU-wide Notified bodiesCE markingMedical devicesIn vitro diagnostics
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